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Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers (PIPOX)

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ClinicalTrials.gov Identifier: NCT03294252
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

Tracking Information
First Submitted Date  ICMJE September 22, 2017
First Posted Date  ICMJE September 27, 2017
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE May 24, 2017
Estimated Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
maximal Tolerated Dose [ Time Frame: 8 to 12 weeks ]
maximal tolerated dose 3x3 patients inclusion(modified fibonacci dose escalation)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • cumulative toxicity after the end of the CIPPA sessions received (maximum 5) at the same dose level [ Time Frame: 24 months ]
    with CTC-AE scale
  • overall survival [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • toxicity [ Time Frame: 24 months ]
    with CTC-AE scale
  • overall survival [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers
Official Title  ICMJE Phase I / II Dose Escalation of Oxaliplatin Via a Laparoscopic Approach of Aerosol Pressurized Intraperitoneal Chemotherapy for Nonresectable Peritoneal Metastases of Digestive Cancers (Stomach, Hail and Colorectal)
Brief Summary

Current curative treatment of digestive peritoneal carcinomatosis consists of complete cytoreduction surgery associated with intraperitoneal chemotherapy. This treatment has important limits: a high morbimortality and the impossibility of repeating the sessions. The majority of patients are therefore treated with systemic chemotherapy, which despite its progress, remains palliative.

Pressurized Intraperitoneal aerosol chemotherapy (PIPAC) has many advantages: under laparoscopy, low morbidity, good intratumoral penetration of cytotoxics, possibility of repeating the sessions and low financial cost.

Therefore, the investigator propose a phase 1 study, in colorectal and stomach cancer, with oxaliplatin doses escalation in Pressurized Intraperitoneal aerosol chemotherapy. It would allow a better tumor response, with potentially few risks and thus improve survival in patients with digestive peritoneal carcinoses, increasing access to cytoreductive surgery.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Digestive Cancer
Intervention  ICMJE
  • Drug: 5-Fluorouracil
    Presentation: Concentrated solution for concentrated infusion in vials containing 250 mg, 500 mg, 1 g and 5 g, in 5 ml, 10 ml, 20 ml and 100 ml respectively, providing a 50 mg / ml solution. Dosage: 400mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.
  • Drug: L-Folinic acid
    Presentation: lyophilisate for parenteral use, dosed at 25 mg, and in the form of a solution for injection by IM or IV dosed at 25 mg / 2.5 ml. Dosage: 20mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.
    Other Name: ELVORIN
  • Drug: Oxaliplatin
    Concentrated solution for infusion dosed with 50 mg and 100 mg. Dosage: depending on the dose range assigned to inclusion (from 90mg / m2 to 300mg / m2). Administration: the solution is packaged in a syringe which is subsequently used for injection and not in a conventional bag. The product is administered in a high-pressure injector, during the PIPAC. Day of administration : J1 of PIPAC
Study Arms  ICMJE Experimental: Oxaliplatin
The experimental drugs used in this protocol are Oxaliplatin, 5-Fluorouracil and L-Folinic acid. All are used as part of their marketing authorization, with the exception of Oxaliplatin as regards its mode of administration specific to the CIPPA procedure (injection and nebulisation in intraperitoneal).
Interventions:
  • Drug: 5-Fluorouracil
  • Drug: L-Folinic acid
  • Drug: Oxaliplatin
Publications * Dumont F, Senellart H, Pein F, Campion L, Glehen O, Goere D, Pocard M, Thibaudeau E. Phase I/II study of oxaliplatin dose escalation via a laparoscopic approach using pressurized aerosol intraperitoneal chemotherapy (PIPOX trial) for nonresectable peritoneal metastases of digestive cancers (stomach, small bowel and colorectal): Rationale and design. Pleura Peritoneum. 2018 Sep 15;3(3):20180120. doi: 10.1515/pp-2018-0120. eCollection 2018 Sep 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 7, 2021
Estimated Primary Completion Date September 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient age ≥ 18 years
  2. Histological or cytological diagnosis of peritoneal carcinoma of colorectal, gastric or gray primitive
  3. Having previously received at least 3 months of systemic chemotherapy for metastatic disease (type of chemotherapy left to the discretion of each investigator). Patients who received chemotherapy with bevacizumab (Avastin®) more than 2 months ago may be included.
  4. Irritable or extensive peritoneal carcinosis:

    Extended peritoneal carcinoma of gastric adenocarcinoma (PCI score> 5) Extended peritoneal carcinoma of adenocarcinoma (PCI score> 13) Extended peritoneal carcinoma of colorectal adenocarcinoma (PCI score> 15)

  5. ECOG performance index < or = 2 (see Annex 8)
  6. Life expectancy> 3 months
  7. Peripheral neuropathy grade ≤ 1
  8. Hematological function: Hemoglobin ≥ 9 g / dL, leukocytes ≥ 4000 / mm3, PNN ≥ 1500 / mm3, platelets ≥ 100 000 / mm3
  9. creatinine clearance> 50 mL / min (cockcroft and Gault formula)
  10. Hepatic function: Total bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 3 x ULN, Alkaline phosphatases ≤ 3 x ULN
  11. Patient without deficiency or with partial deficiency in Dihydropyrimidine dehydrogenase (i.e. DPD)
  12. Effective contraception for women of childbearing age
  13. Informing the patient and obtaining free, informed and written consent signed by the patient and his / her investigator.
  14. Affiliated subject or beneficiary of the social security scheme.

Exclusion Criteria:

  1. Patients who received bevacizumab (Avastin®) less than 2 months ago can not be included
  2. Extra-peritoneal metastases, except for less than 3 pulmonary nodules (each size <5mm)
  3. Known hypersensitivity to Oxaliplatin
  4. Complete deficiency of Dihydropyrimidine dehydrogenase (i.e. DPD)
  5. Grade 1> grade 1 peripheral neuropathy due to or not with Oxaliplatin previously used
  6. Active active or other serious underlying disease that may prevent the patient from receiving treatment
  7. Intracranial or intraocular hypertension (ongoing at the time of inclusion)
  8. Severe or Severe Heart Failure (ongoing at the time of inclusion)
  9. Complete intestinal obstruction (ongoing at the time of inclusion)
  10. Other concurrent cancer or history of cancer other than in situ cancer of treated cervix or basal cell carcinoma or squamous cell carcinoma
  11. Pregnant or nursing women
  12. Persons deprived of their liberty or under guardianship or unable to give their consent
  13. Inability to submit to medical follow-up of the trial for geographical, social or psychological reasons
  14. Long-term corticosteroids (duration> 3 months), except for weaning for at least 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: DUMONT Frederic, MD +33 2 40 67 99 00 frederic.dumont@ico.unicancer.fr
Contact: DEBEAUPUIS Emilie +33 2 40 67 99 00 emilie.debeaupuis@ico.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03294252
Other Study ID Numbers  ICMJE ICO-N-2016-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Cancerologie de l'Ouest
Study Sponsor  ICMJE Institut Cancerologie de l'Ouest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: DUMONT Frederic, MD Institut de Cancérologie de l'Ouest
PRS Account Institut Cancerologie de l'Ouest
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP